Obesity Clinical Trial
Official title:
Microclinic Social Network Behavioral Health Trial for Obesity and Metabolic Risk Factor Control in Jordan
NCT number | NCT01818674 |
Other study ID # | WDF2010-2014 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2012 |
Est. completion date | October 2019 |
Verified date | January 2024 |
Source | Microclinic International |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This 3-armed randomized controlled trial aims to evaluate the effectiveness of The Microclinic Behavioral Health Program in improving obesity and diabetes risk factors through a behavioral intervention program structured to enhance and promote social-network interactions and social support. The full version of the Microclinic Behavioral Health Program (Full MCP) with program-activated social-network interactions-with shared access to diabetes education, technology, and group support to promote weight and metabolic control through diet, exercise, medication adherence, and blood pressure management. Participants play a role in the collective effort to combat diabetes and solidifying self-management behavioral skills through peer-monitoring and encouragement of lifestyle behaviors. The study may yield valuable information on the impact of social support and social network interactions for enhancing body weight and blood sugar control. We compare the full MCP intervention, to a basic MCP intervention with more limited classroom interaction, and to an parallel monitoring control arm. And we aim to understand how metabolic changes over time relate to the cross-propagation of health behaviors between persons in social networks. This Microclinic Behavioral Health Program was established in collaboration with the Royal Health Awareness Society (RHAS) and the Jordanian Ministry of Health (MoH).
Status | Completed |
Enrollment | 914 |
Est. completion date | October 2019 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. diagnosed with type 2 diabetes, pre-diabetes, or 'at-risk for diabetes' (defined below) 2. live in the catchment area of the study 3. provide informed consent to participate. Exclusion Criteria: 1. participants who are not diagnosed with type 2 diabetes, pre-diabetes, or 'at-risk for diabetes' 2. are not able to provide informed consent due to mental illness 3. women who are pregnant. - Pregnant women may participate in consultation with their physician. However, data related to their participation in the trial will not be included in data analysis. 'At-risk of diabetes' is defined as either: a) having a history of diabetes in close family AND being overweight/obese, or b) having a family history of diabetes AND having either high BP or high serum cholesterol. |
Country | Name | City | State |
---|---|---|---|
Jordan | Abu Nseir Ministry of Health Center | Amman | |
Jordan | Kreibet Al Souq Ministry of Health Center | Amman | |
Jordan | Naour Ministry of Health Center | Amman |
Lead Sponsor | Collaborator |
---|---|
Microclinic International | Jordanian Ministry of Health (MoH), Royal Health Awareness Society (RHAS) |
Jordan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Longitudinal change in body weight across all trial arms, over entire study | Change in body weight from baseline, a joint test of differences across all trial arms | Overall change across baseline, to 6 months, to 2 years | |
Primary | Longitudinal change in fasting blood glucose across all trial arms, over entire study | Change in fasting blood glucose from baseline, a joint test of differences across all trial arms | Overall change across baseline, to 6 months, to 2 years | |
Primary | Longitudinal change in glycosylated hemoglobin (HbA1c) across all trial arms, over entire study | Change in HbA1c from baseline, a joint test of differences across all trial arms | Overall change across baseline, to 6 months, to 2 years | |
Primary | Longitudinal change in blood pressure across all trial arms, over entire study | Change in mean arterial pressure (indexed from systolic and diastolic blood pressure) from baseline, a joint test of differences across all trial arms. mean arterial pressure was calculated using the clinical formula MAP=(SBP + (2*DBP))/3) | Overall change across baseline, to 6 months, to 2 years | |
Primary | Temporally investigate the causal induction of cascading changes in body weight between follow-ups on subsequent weight changes in other participants. | Using time intervals between follow-ups analyzed as separate induction timeframe windows, we estimate how weight loss observed in a previous time window predicts body weight change in subsequent followup intervals of the other participants. | Change from each session (weekly, biweekly, triweekly), on each subsequent session, during 6 month intervention period. | |
Secondary | Relative changes in body weight between individual trial arms | Cross comparisons in longitudinal change in body weight between A vs. C, B vs. C, A vs. B. | Change from baseline, at 6 months, at 2 years | |
Secondary | Relative changes in fasting glucose between individual trial arms | Cross comparisons in longitudinal change in fasting glucose between A vs. C, B vs. C, A vs. B. | Change from baseline, at 6 months, at 2 years | |
Secondary | Relative changes in HbA1c between individual trial arms | Cross comparisons in longitudinal change in HbA1c between A vs. C, B vs. C, A vs. B. | Change from baseline, at 6 months, at 2 years | |
Secondary | Relative changes in blood pressure between individual trial arms | Cross comparisons in longitudinal change in mean arterial pressure (indexed from systolic and diastolic blood pressure) between A vs. C, B vs. C, A vs. B. (mean arterial pressure was calculated using the clinical formula MAP=(SBP + (2*DBP))/3) | Change from baseline, at 6 months, at 2 years |
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